Each year, thousands of new medical devices enter the commercial
market. But before any of these products land on the shelf, they must
pass through the gatekeeper--the US. Food and Drug Administration.
Though the FDAs approval process can be complicated, timely and often
expensive, there are a few things that can simplify the experience.

The FDA Classification System

Having spent more than 25 years in the medical device industry,
Stephanie Erskine is no stranger to the nuances of working with the FDA.
"The FDAs mission is to protect public health," says Erskine,
who has served as chief regulatory affairs officer at Merit Medical for
nearly a decade.

"If I'm developing a device, I have to first look at its
class within the FDA classification scheme" Erskine says.
"That [classification] will drive the regulatory process to either
clear a device for market or get the device approved for market"

The FDA has established three classes of medical devices, based on
the level of regulatory control required to assure the products safety
and effectiveness.

Class I devices--those subject to general controls, such as
drainage catheters, occlusive wound dressings and scalpels--pose the
least risk to users and are thus the least burdensome to bring to
market.

Though Class I devices must be listed with the FDA, they generally
do not need to go through the agency's review process. For these
devices, "a manufacturer takes complete responsibility for
manufacturing the device in accordance with the quality system
regulations" Erskine explains. Once the requirements have been met,
the manufacturer is free to launch the product.

Clearance for a Class II device-such as a diagnostic catheter,
guide wire or vascular introducer--is a bit more complicated. These
products are required to go through the FDA's pre-market
notification review process. To do so, a manufacturer must complete a
pre-market notification submission [510(k)] that contains data
demonstrating the device's safety and effectiveness. Some Class II
devices also require human clinical trials.

A new Class II device will also be cleared if the manufacturer can
show that it is "substantially equivalent" to a device that is
already on the market. The FDA has 90 days to review a manufacturers
510(k), but recent changes at the agency have resulted in this process
often taking much longer.

The Rigorous Approval Process

"Class III devices involve a much more rigorous process,"
Erskine says. Devices in this category, including those that support or
sustain life, pose serious potential risks, or that need added control
measures to demonstrate safety and effectiveness, require more oversight from the FDA.

Whereas a Class 1 device must only be listed with the FDA, and a
Class II device must be cleared by the FDA, a Class III device must be
approved by the FDA.

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"Generally speaking, human clinical studies are required for
Class III devices in order to demonstrate their safety and
effectiveness," Erskine says. Her company is currently conducting a
human clinical trial for a Class III device, an embolic for the
treatment of hepatocellular carcinoma.

The manufacturer is responsible to develop the clinical trial
protocol, which must then be approved by the FDA. "There is usually
a lot of back and forth before both parties come to an agreement on
exactly what the trial she will be, how many patients will be enrolled,
whether it needs to be multi-center or single site, etc.," Erskine
says. "The negotiation process can take quite a while."

Though the FDA does not oversee the actual clinical trials, it may
conduct audits to make sure all regulations are being followed. After
the trials have been completed, the manufacturers test and clinical data
are reviewed by the FDA. If the data demonstrate the devices safety and
effectiveness, the agency will approve the device for marketing.

A Changing Regulatory Landscape

Beyond the rigors of the complicated applications and clinical
trials, manufacturers must also be willing to ride the tides of a
changing FDA.

"The most challenging part of working with [the FDA] is that
its a moving target," Erskine says. In addition to substantial
turnover within the agency, the FDA frequently releases new guidance
documents, changes direction on several different topics, and
reevaluates the 510(k) process.

"Sometimes the agency will have a change in their thinking or
in their way of reviewing a device that goes above and beyond what they
have published in guidance documents" she adds. "That makes it
even more critical to engage them in discussions prior to our
submissions."

Though review time has a tendency to lag, Erskine says the pace at
which new medical products are being developed is rapidly accelerating.
"We fully believe in expanding our product offering to better meet
practitioners' needs in the markets we serve," Erskine says of
Merit Medical, which shows no signs of slowing down.

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